510(k) Report

Devices descending from K041903

75 later devices reach Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112391Fujinon ColonoscopesFujinon, Inc.201233—
+1K090116Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15Fujinon, Inc.200945—
+2K183683FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5Fujifilm Corporation20192—
+2K162428DiLumen Endolumenal Interventional PlatformLumendi, LLC20167—
+2K143556Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc.201519—
+2K142629EG-530CT, EG-530D, EC-530DL, and ES-530WE EndoscopesFujifilm Medical System U.S.A., Inc.20156—
+2K132210Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc.201425—
+2K122565Arc EndocuffBoddingtons Plastics, Ltd.20124—
+2K102616Naviaid Balloon Guided Colonoscopy (BGC) DeviceSmart Medical Systems, Ltd.20102—
+2K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.20097—
+2K091773Fujinon Sterile OvertubesFujinon, Inc.20090—
+3K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation20240—
+3K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm Corporaton20231—
+3K213773Insufflation Retention DeviceBpendo, LLC20221—
+3K213195Balloon BS-3Fujifilm Corporation20212—
+3K210162Endoscope Model EI-740D/SFujifilm Corporation20215—
+3K183032FUJIFILM Double Balloon Endoscope EI580BTFujifilm Corporation20195—
+3K180341FUJIFILM 600 Series Endoscope EG-600WR v2Fujifilm Corporation20181—
+3K173317DiLumen C2; DiLumen Tool MountLumendi, LLC20184—
+3K172916FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM…Fujifilm Corporation201818—
+3K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc.20178—
+3K162205Arc EndoCuff and Arc EndoCuff VisionBoddingtons Plastics, Ltd.20160—
+3K160846AmplifEYEMedivators, Inc.20160—
+3K160196Fujifilm Video Colonoscope Model EC-600WL V2Fujifilm Medical Systems U.S.A, Inc.201619—
+3K153483Balloon controller PB-30Fujifilm Medical Systems U.S.A, Inc.20151—
+3K143732FUJIFILM Endoscope Models EC-600HL and EC-600LSFujifilm Medical Systems U.S.A, Inc.20152—
+3K133359EndoringsEndo-Aid, Inc.20141—
+3K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+3K111760Naviaid (TM) BGC DeviceSmart Medical Systems, Ltd.20111—
+4K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S20260—
+4K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.20260—
+4K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation20260—
+4K261587Insufflation Retention Device (IRD) (11173-325-101)BPEndo, LLC20260—
+4K252457Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd.20260—
+4K242635Endoscopic Distal Attachment (AF-D series)Alton (Shanghai) Medical Instruments Co., Ltd.20250—
+4K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…Fujifilm Corporation20250—
+4K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation20251—
+4K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope…Fujifilm Corporation20243—
+4K232327EndorailEndostart S.R.L.20240—
+4K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water…Medivators (A Subsidiary of Steris Corporation)20233—
+4K232028Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base…Iq Endoscopes Limited20230—
+4K232314Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)FUJIFILM Healthcare Americas Corporation20231—
+4K221551FUJIFILM Endoscope Model EI-740D/SFujifilm Corporaton20232—
+4K213095andorate Suction Valve, andorate Air/Water ValveGa Health Company Limited20220—
+4K211819DiLumen C2 and Tool MountLumendi, LLC20213—
+4K210915Pathfinder Endoscope CapNeptune Medical, Inc.20210—
+4K200495Andorate Disposable Air/Water Valve, Andorate Disposable Suction ValveGa Health Company Limited20201—
+4K200388Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer ConnectorGa Health Company Limited20200—
+4K193123FUJIFILM Distal Cap Models 33-40Fujifilm Corporation20192—
+4K192664FUJIFILM Endoscope Model EC-760Z-V/LFujifilm Corporation20190—
+4K183572FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/LFujifilm Corporation20195—
+4K190649FUJIFILM Endoscope Model EC-760S-V/LFujifilm Corporation20193—
+4K182836FUJIFILM Endoscope Model EG-740NFujifilm Corporation20194—
+4K190030Embrella Endoscopic Distal AttachmentMicro-Tech (Nanjing) Co., Ltd.20190—
+4K162622Fujifilm Endoscope Models EC-600HL and EC-600LSFujifilm Medical Systems U.S.A, Inc.20161—
+4K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+4K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+4K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+4K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+5K260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems Corporation20260—
+5K253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood…Fujifilm Corporation20260—
+5K243512FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope…Fujifilm Corporation20250—
+5K250140Defendo Fujifilm 700 Single Use Cleaning AdapterSteris Corparation20250—
+5K242779Hood (DH-083ST)Fujifilm Corporation20240—
+5K240352Defendo Single Use Cleaning Adapter for Olympus EndoscopesSTERIS Corporation20241—
+5K232118ANDORATE® Valve KitGa Health Company Limited20230—
+5K223827FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01Fujifilm Corporation20231—
+5K221452DiLumen C1, EZ1 and Tool MountLumendi, LLC20232—
+5K212296Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2Fujifilm Corporation20210—
+5K190669EndoticsEra Endoscopy S.R.L.20200—
+5K180405FUJIFILM Endoscope Models EC-600HL and EC-600LSFujifilm Corporation20180—
+5K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+6K243075Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096…STERIS Corporation20240—
+6K231323Ancora-SBAspero Medical, Inc.20231—
+7K260314Ancora-SBAspero Medical, Inc.20260—